Evaluation of Nexpowder Application to Prevent Delayed Bleeding After Large Colorectal Endoscopic Mucosal Resection
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 304
- 试验地点
- 2
- 主要终点
- Severe post-resection bleeding rate up to Day 30
研究概览
简要总结
Delayed bleeding is the most frequent (5 to 15%) and challenging complication after large colorectal polypectomy. Different preventive treatments, such as the prophylactic use of clips, have been tried to prevent the occurrence of delayed bleeding, but to date, no treatment has clearly shown its effectiveness. In addition, preventive hemostasis with clips is difficult and costly. A newly developed endoscopic hemostatic powder generating gelation effect (Nexpowder) may be an effective alternative to prevent post polypectomy bleeding in patients treated by endoscopic mucosal resection (EMR) for large superficial colorectal lesions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •More than 18 years old
- •Indication of EMR for a superficial nonpedunculated colorectal lesion
- •Higher risk of bleeding (score GSEED RE2 ≥ 7*)
- •*Score GSEED RE2 (Albeniz et al GIE 2020):
- •Proximal location (cecum to transverse included) : 3 points
- •Antiplatelets or anticoagulation use: 3 points
- •Lesion size ≥ 40 mm: 1 point
- •ASA III-IV or major comorbidity: 1 point
排除标准
- •Patients susceptible to allergic reactions to certain substances in Nexpowder
- •More than one colorectal lesion
- •Suspicion of invasive cancer (Kudo V, Sano IIIb, Connect III), macronodular more than 1 cm, depressed area (Paris IIc)
- •Pedunculated polyps (Ip from Paris classification) or ulcerated polyps (III)
- •Recurrent or residual lesion after endoscopic or surgical resection
- •Poor bowel preparation quality (Boston score < 6)
- •Inflammatory bowel disease (IBD)
- •Patients with a platelet count of 50,000/mm3 or less
- •Patients with acquired (non-medicated) or inherited bleeding disorders
- •Patients with advanced cancer or inflammatory bowel disease, including ulcerative colitis (with colonic involvement)
- •Contraindication to general anesthesia
- •Women who are pregnant or who wish to become pregnant during the study or women who are breastfeeding.
- •Children, immunocompromised persons and persons over 90 years of age
- •Patients already participating or scheduled to participate in other clinical trials
- •Lesion previously resected by endoscopy
- •Patient with an initial metastatic lesion before colonoscopy
- •Patient unable to give personal consent
- •Lack of signed informed consent
结局指标
主要结局
Severe post-resection bleeding rate up to Day 30
时间窗: 30 days
Number of patients with a severe post-resection bleeding. It is defined as bleeding requiring a new endoscopy or surgery, OR a radiological embolization, OR blood transfusion, OR a re-hospitalization OR haematochezia with hemoglobin loss \> 2 g/dl
次要结局
- Rate and duration of hospitalizations(30 days)
- Stenosis rate(30 days)
- Bowel obstruction rate(30 days)
- Rate of cases requiring transfusion related to post-EMR bleeding(30 days)
- Delayed perforation rate(30 days)
- Post coagulation syndrome(30 days)
- The success rate of Nexpowder application(Day of resection)
研究者
Gabriel RAHMI
Principal Investagator, Medical Doctor
French Society of Digestive Endoscopy